FDA Adverse Event
Malfunction
Summary report: N
PUMP MMT-722NAL PRDGM INSULIN CL EN
MDR report key: 1881498
·
Received October 19, 2010
Report
- Report Number
- 2032227-2010-83000
- Event Type
- Malfunction
- Date Received
- October 19, 2010
- Date of Event
- October 3, 2010
- Report Date
- October 3, 2010
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- MDS
- PMA / PMN Number
- P980022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE INSULIN PUMP WAS RECEIVED WITH A BLANK DISPLAY DUE TO A CORRODED ELECTRONIC ASSEMBLY AND MOTOR. UNABLE TO VERIFY THE FROZEN DISPLAY DUE TO THE BLANK DISPLAY.
Description of Event or Problem · 1
THE CUSTOMER REPORTED A FROZEN SCREEN AND UNRESPONSIVE BUTTONS. THE CUSTOMER ALSO REPORTED A CRACK ON THE SCREEN, AS WELL AS CONDENSATION UNDERNEATH THE SCREEN. ADVISED THAT THE INSULIN PUMP WOULD BE REPLACED. NOTHING FURTHER WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PUMP MMT-722NAL PRDGM INSULIN CL EN | INFUSION PUMP | MDS | MEDTRONIC MINIMED | MMT-722NAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR |